申请企业

TERUMO BCT

药品名称

Isoplate Solution, unidentifiable product

状态

完成

承诺描述

Conduct a controlled postmarketing study to track adverse events in the recipients of Trima Accel collected platelets stored in 65% Isoplate/ 35% plasma. Adverse events (e.g., transfusion reactions) will be captured through active surveillance of the test and the control products (platelets stored in plasma). Transfusion reactions will be classified and compared by type (e.g., TRALI, febrile non-hemolytic transfusion reaction, allergic reaction, etc.).

承诺状态描述

报告接收日期

2018/5/16 0:00:00

批准日期

2013/3/5 0:00:00

截止日期

CDER/CBER

CB

子类型标记

F